title: Recurrence rate of superficial basal cell carcinoma following treatment with imiquimod 5% cream: conclusion of a 5-year long-term follow-up study in Europe.
abstract: Imiquimod 5% cream is an immune response modifier approved for the treatment of superficial basal cell carcinoma (sBCC) once daily, 5 x per week for 6 weeks. This report reveals the final results of a 5-year follow-up study to evaluate the recurrence rate of sBCCs treated with imiquimod. As previously reported, 182 patients were enrolled in the study and 163 (89.6%) had no clinical evidence of their target sBCC at the 12-week post-treatment assessment; these 163 were followed for up to 5 years. During the follow-up period, 18 clinical recurrences occurred at the target tumour site, 8 and 10 of which occurred during the first 6 and 12 months of follow-up, respectively. The 5-year Kaplan-Meier and life-table estimates for sustained clinical clearance of those patients initially cleared were 84.5% and 86.9%, respectively, and 90.3% considering histology. The estimate of overall treatment success for all treated patients at the end of follow-up was 77.9% (80.9% considering histology). The data support clinical assessment of initial response as predictive of long-term outcome. Most of the recurrences occurred early, indicating that careful follow-up is important during the first year after treatment.
authors.affiliation: Clinic for Dermatology and Venereology, Otto von Guericke University of Magdeburg, Leipziger Str. 44, 39120 Magdeburg, Germany. harald.gollnick@medizin.uni-magdeburg.de
authors.forename: Harald
authors.initials: H
authors.lastname: Gollnick
authors.forename: Carlos Guillén
authors.initials: CG
authors.lastname: Barona
authors.forename: Ronald Gj
authors.initials: RG
authors.lastname: Frank
authors.forename: Thomas
authors.initials: T
authors.lastname: Ruzicka
authors.forename: Mosaad
authors.initials: M
authors.lastname: Megahed
authors.forename: Joachim
authors.initials: J
authors.lastname: Maus
authors.forename: Ullrich
authors.initials: U
authors.lastname: Munzel
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000634:Aminoquinolines / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002280:Basal Cell Carcinoma / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D000077271:Imiquimod; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000634:Aminoquinolines; D000970:Antineoplastic Agents; D000077271:Imiquimod